Michael P. Manfredi
Associate / Atlanta
Michael has an extensive trial and appellate litigation background and has tried dozens of cases before judges and juries. He has represented state officers and officials sued for alleged constitutional violations and tort claims. His experience also includes investigating and mediating allegations of deliberate indifference, wrongful death and, professional negligence under the Georgia Tort Claims Act. Michael achieved multiple Not Guilty verdicts in multi-day, complex felony criminal trials. As an Assistant Attorney General, he garnered the fastest civil defense verdict in the Middle District of Georgia (according to Federal Magistrate Judge Stephen Hyles). He has represented individuals on cases in the 11th Circuit Court of Appeals, the Georgia Court of Appeals, and one case that went to the Georgia Supreme Court. His numerous accomplishments in the courtroom earned him the designation as one of the National Trial Lawyers Top 40 Under 40.
An Atlanta native, Michael graduated from the Marist School in 2002. He went on to earn his Bachelor’s Degree from Wake Forest University in 2007. After college, he returned home for law school, graduating cum laude from the Georgia State University School of Law. While in law school, he was selected for membership on the Moot Court Board, and argued in the New York City Bar Association National Competition. He was subsequently elected by his peers to the position of Moot Court Vice-President. Michael was awarded a full scholarship to attend the prestigious Gerry Spence Trial Lawyers College in Wyoming for litigation attorneys.
In serving the community, Michael is active in Habitat for Humanity, teaches weekly faith formation classes to 4th grade students, and is a volunteer Brazilian Jiu-Jitsu coach to young children.
Michael Manfredi participated again as a judge during Empire Atlanta.
Michael is fluent in Spanish & Italian.
Dave Root and Michael Manfredi Obtain Defense Verdict in Premises Liability Case
Dave Root and Michael Manfredi obtained a defense verdict in a four day premises liability case in Albany, Georgia. Plaintiff was a patron at the American Legion’s restaurant/bar in Albany on Labor Day weekend in 2015. As he was leaving the facility, he got into a scuffle with an employee. It was disputed who initiated the fight. Another employee stepped in to stop the fight and to remove Plaintiff from the club. In the course of the melee, Plaintiff suffered a broken neck and serious spinal cord injury. Plaintiff alleged that the second employee “negligently removed” him and in doing so caused the serious injury. At trial, Plaintiff sought medical expenses, past and future lost wages, and pain and suffering. He asked the jury for $4,000,000+. The jury retired to deliberate for over five hours before returning a defense verdict.
For informational purposes only. Past success does not indicate the likelihood of success in future cases.
Michael Manfredi Participated in the NBI seminar – Accident Scene Investigation Strategies and Successfully Negotiating Wrongful Death with Insurance Companies – Atlanta
September 28, 2017
Michael Manfredi participated in the NBI seminar - Accident Scene Investigation Strategies and Successfully Negotiating Wrongful Death with Insurance Companies on September 28, 2017 at the Doubletree by Hilton Atlanta Perimeter Dunwoody, 4386 Chamblee Dunwoody Road, Atlanta, GA 30341 Michael presented in two sessions: Accident Scene Investigation Strategies: Secrets Adjusters Don't Want You to Know A. Preservation and Spoliation Issues B. Photos and Video Recordings of the Scene C. Spotting Red Flags D. Questions to Always Ask Witnesses E. Working with Law Enforcement to Obtain Evidence F. GPS Evidence: Obtaining, Authenticating and Admitting G. Cell Phone Evidence: Obtaining, Authenticating and Admitting Successfully Negotiating Wrongful Death with Insurance Companies A. Defense Investigation and Strategy of the Wrongful Death Case B. Using Medical Records Effectively C. Creatively Addressing Damages and Maximizing Compensation D. Using Proven Negotiation Techniques E. Determining the Insurance Companies Authority F. What to do When Negotiations Fail G. Minimizing Liens in Wrongful Death or Survival Actions H. Case Law Review
Michael Manfredi Assigned Role of Judge at the Empire Mock Trial – Jonesboro
September 24, 2017
Michael Manfredi took on the role of Judge at the Round 4 Empire Mock Trial being held at the Clayton County Superior Court, 9151 Tara Boulevard, Jonesboro, GA on September 24.
Michael Manfredi participated in the NBI seminar Uninsured and Underinsured Motorist Law – Made Simple
June 27, 2017
Michael Manfredi participated in the NBI seminar Uninsured and Underinsured Motorist Law - Made Simple on June 27, 2017 at the Cobb Galleria Center in Atlanta, GA. Michael presented two sessions, Clarifying UM/UIM Coverage - Carrier Obligations Made Simple and Is the Motorist Underinsured? Easy Ways to Calculate Limits and Damages.
The CLM Greater Atlanta 4th Annual Mardi Gras Event – Melissa Bailey and Michael Manfredi attended
March 7, 2017
Michael Manfredi Presented Is There an App for Liability? The Practice of Law in a Shared Economy – Atlanta
December 9, 2016
Michael Manfredi presented Is There an App for Liability? The Practice of Law in a Shared Economy on December 9 at the Marjorie and Ralph Knowles Conference Center, 85 Park Place NE, Atlanta, GA 30303. There seems to be an ever-increasing number of companies entering the shared economy—from Uber to Airbnb to Roadie, these companies are rapidly restructuring how we operate as consumers. Much of the shared economy business model remains an under-regulated Wild West that presents liability landmines in a number of ways. This presentation included a discussion of recent cases and emerging issues that examine the tension inherent in regulating the sharing economy including insurance, taxes, and consumer rights. Beyond that, there are ethical issues that lawyers encounter both in advising these clients and participating in the shared economy. Please contact Michelle Mattox at firstname.lastname@example.org if you would like more information on this topic. Michael Manfredi produced a paper entitled, Evolving Coverage in an Evolving World: Coverage Issues in the Sharing Economy with a Focus on Transportation Network Services.
Michael Manfredi Served During Round 4 at Empire Atlanta – Mock Trial – The Southern Showdown – October 9
October 9, 2016
Michael Manfredi served as a judge and a juror during Round 4 at Empire Atlanta: The Southern Showdown held on October 9.
Publications and Presentations
Cyber Security and Liability Insurance: Stand-Alone Cyber Policies On The Rise – Cyber Liability Blog Posting by Michael Manfredi
December 5, 2017
Cyber Liability Blog Posting by Michael Manfredi. After companies began electronically storing sensitive business and customer information, the insurance industry focused heavily on privacy protection. Businesses began implementing breach defenses and response protocols in an effort to avoid or mitigate the effects of having personal health information, financial information, trade secrets, or intellectual property stolen or used without authorization. In many cases, hackers held the information hostage and demanded payment of a ransom (“ransomware attacks”) in order to release the information and not expose it to the public. Breaches in privacy protection cause other expenses related to notification, data recovery, public relations management, reputation damages, and others. Thus, cyber insurance became a popular line of coverage offered by insurance companies. Now, with cyber-attacks getting increased media attention, the insurance industry has broadened coverage for cyber security and cyber liability into more areas than just privacy protection. Businesses are learning that cyber breaches do not just affect privacy protection; they can also interrupt business and cause property damage. The most common course of action when a breach is noticed is to stop operations. When systems shutdown, so does the flow of goods and services. When the flow of goods and services stops, money stops coming in. With regard to property damage, many, if not most, businesses now rely on some form of computer-controlled regulation in their buildings. For example, it is common to have a building’s heating and air conditioning set on an electronically-stored schedule. If, however, the heat does not turn on when it’s supposed to, water lines can freeze. If there is water in the pipes, that too freezes and, when the ice expands, it can cause the pipes to break, releasing water into the building. As another example, consider factories that rely on computer-controlled cooling fans. If they are stopped, machines overheat and start fires. These kinds of losses are notable particularly because they do not require activity on the part of a sophisticated hacker. Rather, human error and technical glitches can cause these losses. Hence, new lines of insurance coverage are popping up in the marketplace. Cyber coverage for business interruption and property damage are starting to be offered as umbrella coverage over property, kidnap, and ransom policies. Stand-alone cyber policies are also being offered. However, the market is young and maturing. Policyholders need to review and re-review their policies to ensure proper wording for issues such as cyber extortion, business interruption, contingent business interruption, and cyber property-related coverage. To keep premiums low in a time when cyber breaches regularly make front-page news (Equifax, Home Depot, etc.), businesses should be ready to demonstrate breach-readiness, such as the establishment of incident response teams, as well as internal and external cyber security controls. Please click here for more information regarding our Cyber Liability Blog.
Georgia Supreme Court Clarifies Rule on Intervening Acts and Causation – Insurance Coverage Corner Blog Posting by Michael Manfredi
November 8, 2017
Insurance Coverage Corner Blog Posting by Michael Manfredi. In Georgia, there is no requirement that an intervening act be wrongful or negligent to break the causal chain of a tortfeasor's act or omission and a plaintiff's injury. Rather, the analysis is simply whether the concurrence of an intervening act was reasonably foreseeable by a defendant, or if the intervening act was triggered by the defendant's conduct. In Jordan v. Everson, Ben Everson's mother drove him to the emergency room at Phoebe Sumter Medical Center in Americus, Georgia because he was hearing voices and hallucinating. There, Dr. Brian Jordan diagnosed him with obsessive-compulsive disorder and discharged him. Before leaving, ER personnel called and set up an appointment for May 1 at a mental health facility near the Medical Center. However, the Eversons, originally from Durham, North Carolina, had a number of contacts at Duke University Hospital. Mr. Everson began calling around to see if he could get his son in to see someone at Duke. He ultimately made an appointment for Ben to see a psychiatrist at Duke on the afternoon of May 1st. During the drive to North Carolina, Ben unbuckled his seatbelt, jumped out of the moving car, and ran down the highway. He was hit and killed by a vehicle traveling on the interstate. Dr. Jordan filed a motion for summary judgment, arguing that the intervening act of driving Ben to a hospital hours away, rather than taking him to the local facility, broke the causal chain. The trial court denied the motion, and the Court of Appeals affirmed. In affirming the trial court’s denial of Dr. Jordan's motion, the Court of Appeals relied on the following line, taken from the opinion in Goldstein, Garber & Salama v. J.B., 300 Ga. 840 (2017), where the Georgia Supreme Court said, “that its negligence is not the proximate cause of the plaintiffs injuries, but that an act of a third-party intervened to cause those injuries, the rule is that an intervening and independent wrongful act of a third person producing the injury, and without which it would not have occurred, should be treated as the proximate cause, insulating and excluding the negligence of the defendant.” Now, the Georgia Supreme Court took the opportunity to clarify that line. The Court said that the "Court of Appeals read too much into that sentence." It distinguished Goldstein by explaining that it was addressing whether a sexual assault, "an indisputably wrongful act," intervened to break the chain of causation. "We did not consider whether an intervening act always must be wrongful...." And in fact, an intervening act does not always have to be wrongful in order to insulate and exclude the negligence of a defendant. So, when assessing and evaluating a possible defense based on the acts of third-parties, the analysis should include whether the defendant (1) knew or should have known whether the intervening act would occur, or (2) triggered, or caused, the act to occur. If the answer to both questions is "no," then a motion for summary judgment may be appropriate. To carry the application of this rule further, when analyzing claims, professionals and attorneys should consider whether the acts of a third-party intervened in such a way that the third-party assumed some level of responsibility for the plaintiff’s ultimate injuries. With Georgia's broad comparative negligence rule, a defendant's exposure could be significantly reduced, or eliminated altogether. The Jordan v. Everson opinion is available at 2017 Ga. LEXIS 884, 2017 WL 4582408 (October 16, 2017). Please click here for more information on our Insurance Coverage Corner blog.
Cyber Attacks: Prepare, Prepare, Prepare – Cyber Liability Blog Post by Michael Manfredi
April 10, 2017
Blog Post by Michael Manfredi. A cyber attack is any incident in which sensitive, confidential information is stolen or used by unauthorized individuals. Cyber breaches may involve the theft or unauthorized use of personal health information, financial information, trade secrets, or intellectual property. The consequences of a successful attack may include embarrassment, bad press, loss of business, loss of huge amounts of money - whether by theft or through the payment of ransoms ("ransomware attacks"), civil penalties, and even criminal prosecution. When a breach occurs, companies spend enormous amounts of money hiring forensic investigators to figure out what was breached, who did it, the type of information accessed, and the extent of the damage. They spend even more money determining how the breach happened, and what steps are needed to defend against future attacks. Finally, they are forced to pay monitoring firms for years to come in order to protect customers from any future damage, protect the company brand, and reestablish trust with current and potential clients. It is essential that corporate executives and owners make cyber security a priority in both planning and budgeting. While responding to a breach is expensive, the true cost to the company cannot be measured in dollars and cents. Tech-savvy customers want to know that their personal and/or financial information is safe from the rest of the world. To instill confidence in potential customers (and avoid paying the costs associated with cleaning up a cyber spill), companies need to have a gameplan in place before a breach ever occurs. The establishment of incident response teams is a vital first step. The team should be made up of individuals that are team-oriented, detail-focused, and capable of sticking to the gameplan when stress levels rise. These carefully-selected individuals must understand the importance of their roles and devote themselves to constant learning as cyber security issues evolve. Companies might also consider employing full-time services from outside providers. In the end, it will be much more expensive to respond to a successful breach than to avoid one in the first place. For more information on our Cyber Liability Blog or to subscribe, click here.
No Bad Faith in Uninsured Motorist Claim Where Damages in Dispute – Insurance Coverage Blog Post by Michael Manfredi
March 31, 2017
This Tuesday, the 11th Circuit affirmed a summary judgment granted in favor of State Farm, holding that State Farm was not legally obligated to pay the claim since the amount of damages was in dispute.
Alabama law states that there can be no breach of an uninsured motorist contract, and therefore no claim for bad faith, unless and until the insured proves that he is "legally entitled" to recover. In this case, the record established that the other driver was at-fault. However, the analysis did not stop there.
The Court provided that, to establish that a plaintiff is "legally entitled" to recover, both liability and damages must be proved. Here, the record was clear that State Farm disputed the amount of damages claimed by plaintiff. As such, his claims for breach of contract and bad faith were properly dismissed as premature.
The case is Broadway v. State Farm Mut. Ins. Co., 2017 U.S. App. LEXIS 5350 (March 28, 2017).
FBI Not Vicariously Liable For Fire Damage – Blog Posting by Michael Manfredi
March 6, 2017
11th Circuit judges Stanley Marcus, Julia Carnes, and Jill Pryor upheld the decision that the FBI was not vicariously liable for fire damage to a Country Inn and Suites hotel caused when FBI Special Agent Michael Siegling (“Siegling”) “negligently discarded“ his cigarette. Siegling stayed at a Country Inn and Suites hotel in Huntsville, Alabama while attending a voluntary 6-week training course on hazardous materials. In the evenings, he frequently smoked cigarettes on the balcony of his second-floor hotel room. After a fire spread one evening at the hotel, rendering an entire wing uninhabitable, the Fire Marshal determined that the cause was a “negligently discarded” cigarette from the balcony of Siegling’s room. Acadia Insurance Company, which indemnified the hotel, brought a subrogation claim against the United States under the Federal Tort Claims Act. Acadia argued that the FBI was vicariously liable since it paid for Siegling to stay in a smoking room while attending the FBI training course. Under Alabama law, the rule for determining whether the conduct of an employee is within the scope of his employment is substantially that if an employee is engaged to perform a certain service, then whatever he does to that end, or in furtherance of the business, is within the scope of the employment. Solmica of Gulf Coast, Inc. v. Braggs, 232 So. 2d 638, 642 (Ala. 1970). The 11th Circuit held that Siegling was not acting within the scope of his employment when he discarded the cigarette because he was off duty, not under the FBI’s supervision, and not engaged in activities that furthered its business. Furthermore, the FBI did not pay for his cigarettes. Rather, it prohibited employees from purchasing cigarettes with a government credit card. The 11th Circuit added that no evidence was presented that the FBI was aware that he purchased a smoking room, nor did it require Siegling to stay at that particular hotel. The decision is Acadia Ins. Co. v. United States, 2017 U.S. App. LEXIS 394 , 2017 WL 83379 (11th Cir. 2017). Please click here for more information on our Insurance Coverage Corner Blog.
11th Circuit To Hear Dispute Over Notice Requirements After Dismissal Without Prejudice – Recent Blog Posting by Michael Manfredi
October 24, 2016
Recent blog posting by Michael Manfredi. Since 2008, litigation has been ongoing between G.M. Sign, Inc. and Brink's Manufacturing Co. over allegations that Brink's violated the Telephone Consumer Protection Act by sending out unsolicited faxes without any ability by the recipient to opt out of receiving the faxes. The original 2008 lawsuit was dismissed without prejudice in 2009. G.M. Sign immediately filed an identical suit in Illinois State Court, which settled for $22.54 million. As part of the deal, G.M. Sign was assigned Brinks' insurance rights under its policy with St. Paul Fire & Marine Insurance Co. However, Brink's did not tender the defense of the action brought in Illinois State Court and did not otherwise provide notice to St. Paul of the fact that the suit had been re-filed. In 2014, G.M. Sign went after St. Paul in Georgia federal court. St. Paul responded that it was not required to cover the claim brought in Georgia because, after the 2009 dismissal without prejudice, it did not receive notice of ongoing or re-filed litigation between the parties. St. Paul maintained that Brink's failure to provide notice deprived St. Paul of the ability to consider any settlement demand or otherwise resolve the 2009 action. G.M. maintains that, since the second suit is identical to the first suit, and since St. Paul knew of the first suit, then notice was adequately provided. Judge Eleanor Ross, serving the Northern Federal District of Georgia, ruled that a dismissal without prejudice "means the suit is over." Therefore, an insured must provide notice of a re-filed claim or other litigation, no matter how similar to the first lawsuit it may be. Because no such notice was provided in this case, Judge Ross relieved St. Paul from having to provide coverage. The case has made its way to the 11th Circuit Court of Appeals: G.M. Sign, Inc. v. St. Paul Fire & Marine Ins. Co., 1:14-cv-02977. Please click here for more information on our Insurance Coverage Corner Blog.
Significant Regulations Added Regarding Arbitration Agreements in Long-Term Care Facilities that Accept Medicare and Medicaid Patients – Recent Blog Posting by Michael Manfredi
October 7, 2016
Recent blog posting by Michael Manfredi. Long-term care facilities, i.e., nursing homes, that accept Medicare and Medicaid patients will be subject to some significant changes in regulations on their ability to enter into arbitration agreements with patients.
New Rules and Requirements:The changes are as follows: 1. Pre-dispute binding arbitration agreements are prohibited; 2. The facility cannot require the resident to sign a post-dispute arbitration agreement as a condition of the resident’s continuing to stay at the facility; 3. The ability to enter into post-dispute arbitration agreements with patients are subject to the following regulations:
- The facility must explain the agreement to the resident in a form, manner, and language that the resident understands and have the resident acknowledge that he or she understands the agreement;
- Guardians or representatives of the resident cannot consent to an agreement for binding arbitration on the resident’s behalf unless that person was allowed to do so under state law and has no financial interest in the facility;
- The agreement cannot contain any language prohibiting or discouraging the resident or any other person from communicating with federal, state, or local officials regarding any matter;
- The facility must inform the resident that he or she is waiving his or her right to a jury trial;
- The facility must provide for the selection of a neutral arbitrator and a venue convenient to both parties; and
- Any agreement for binding arbitration must be separate and distinct from any other agreement or paperwork addressing any other issues.
Looking Ahead:The Department addressed one comment in a manner that leads us to believe that we should be on the lookout for similar changes in the next few years. The commenter pointed out that other Medicare and Medicaid healthcare providers utilize arbitration agreements regularly. Therefore, the commenter asked, why were other providers not subject to the same requirements as long-term care facilities? In response, the Department stated that regulations on the use of arbitration agreements by other providers are “beyond the scope of this rule.” However, it continued, “we will retain this comment for review in case there is future rulemaking in this area.” As always, medical professionals and facilities providing care to Medicare and Medicaid patients need to be vigilant about new and/or changing regulations affecting their practice. Please click here for more information on our Health Law and Regulation Update Blog.
Court of Appeals Carefully Distinguishes Medical Malpractice From Ordinary Negligence In Case Resulting In Wrongful Arrest – Recent Blog Posting by Michael Manfredi
October 6, 2016
Recent blog posting by Michael Manfredi. After writing a prescription for 120 pills of hydrocodone, Tami Carter's doctor decided to change the quantity from 120 to 180. When she took the prescription to Walgreens, an employee assumed that Ms. Carter altered the prescription and called her doctor's office to verify the prescription. The on-call physician, a different person than the prescribing doctor, was not aware of the change and did not verify if his partner had done so. When Ms. Carter returned to Walgreens, she was arrested on the spot. She filed two claims: one against the prescribing physician for altering the prescription rather than writing a new one; the other against the medical practice for failing to verify the change. The Court of Appeals dismissed the claim against her doctor, finding that the claim called into question his professional judgment in altering the quantity of pills prescribed, and that Ms. Carter did not attach an expert affidavit to her complaint as required in Georgia for a medical malpractice case. The Court reiterated that "[the] resolution of whether an act or omission sounds in simple negligence or medical malpractice depends on whether the conduct...involved a medical judgment." Her claim against the practice, on the other hand, did not suffer the same fate. The Court found that failing to make an effort to verify the prescription, or having a procedure in place to do so, did not involve professional skill or judgment. Thus her claim against the practice was permitted to go forward. There have been a number of cases involving the distinction between ordinary negligence and medical malpractice recently. While hospitals and many large medical groups have in-house counsel to help guide and counsel practice procedures in order to avoid these types of cases from ever arising, most of the smaller medical practices do not have that luxury. It would be wise to pay attention to these types of decisions as they come out as they tend to be very fact-intensive, and can help prevent avoidable claims against the practice. *The case is Carter v. Cornwell, 2016 Ga. App. LEXIS 528 (Sept. 21, 2016). Please click here for more information on our Health Law and Regulation Update Blog.
Liability Insurers May Be Liable To Double Payment For Failure To Reimburse Medicare Providers – Recent Blog Posting by Michael Manfredi
October 3, 2016
Recent Blog Posting by Michael Manfredi. In a case of first impression in the 11th Circuit, the Court of Appeals held that a private insurance company operating as a Medicare Advantage Organization can sue a primary payor that refuses to reimburse the MAO for a secondary payment. Prior to 1980, Medicare paid for all medical treatment within its scope and left private insurers to pick up the rest. In 1980, in an effort to lower Medicare costs, Congress enacted the Medicare Secondary Payer Act (MSP), which inverted that system: private insurers paid first and Medicare paid what was left. 42 U.S.C. § 1395y(b)(2)(B), entitled "Conditional payment," describes the manner in which Medicare can make a conditional payment notwithstanding its status as secondary payer. When the primary plan does not fulfill its duties, the government may make a payment conditioned on reimbursement from the primary insurer. If the primary insurer does not reimburse the government, then it is liable in the amount of twice the payment owed. Under the Medicare Advantage program, private insurance companies can operate as Medicare Advantage Organizations. As a MAO, the insurer agrees to provide Medicare benefits in return for a per capita fee from the government. In this case, Mary Reale was injured at a condominium complex and brought suit against the complex. Humana, as a MAO, covered Mrs. Reale’s medical bills. In the meantime, Mrs. Reale settled with the complex and its insurer, Western Heritage Insurance Co. Because the MSP provides that Medicare payments are secondary if any other insurer, including a tortfeasor’s insurer, is liable, Humana sought to recover from Western Heritage. Western Heritage refused to pay, arguing that the Medicare statute only allows the Secretary of Health and Human Services to make conditional payments. The Court looked to the regulations governing the Centers for Medicare & Medicaid Services. Under 42 C.F.R. §422.108(f), an MAO “will exercise the same rights to recover from a primary plan…that the Secretary exercises under the MSP regulations….” The Court then applied 42 U.S.C. § 1395y(b)(3)(A), which provides that, if a primary insurer fails to reimburse the Government, then damages “shall be in an amount double the amount otherwise provided.” Therefore, the Court upheld an order awarding Humana twice the amount it was originally owed by Western. *The case opinion can be found at Humana Medical Plan, Inc. v. Western Heritage Ins. Co., 2016 WL 4169120 (11th Cir. Aug. 8, 2016). Please click here for more information on our Health Law and Regulation Update Blog.
Carlock, Copeland and Stair, LLP Welcomes Attorneys To Atlanta and Charleston Offices
August 24, 2016
Shoulder Dystocia: The Oft-Litigated Medical Claims – How to Avoid Liability and Do It Right – Recent Blog Posting by Michael Manfredi
August 9, 2016
Recent blog posting by Michael Manfredi. A Federal judge in the Middle District of Georgia entered an astounding $6,000,000 verdict for a family whose child suffered a brachial plexus injury following a delivery complicated by shoulder dystocia. Coleman v. United States, 2016 U.S. Dist. LEXIS 102915, 1:14-CV-168(WLS) (M.D. Ga. 2016). The judge’s finding emphasizes two things that all OB/GYNs, nurses, and other medical professionals in the field of obstetrics and gynecology should note: (1) Review the mother’s medical history as early as possible; and (2) Do not pull on the child’s head. In Coleman, the mother had three prior vaginal deliveries, two of which were complicated by shoulder dystocia. The same Nurse Midwife involved with the delivery in this case was involved in those two prior deliveries and actually documented the relevant medical history herself. She did not, however, inform the delivering physician or the mother about the prior shoulder dystocias. During labor, the doctor used a vacuum extractor one he realized that the child’s fetal heart rate was low. When the head delivered, he recognized the dystocia and called for the McRoberts maneuver and the application of suprapubic pressure. The doctor and nurse then “pulled on [the child’s] head three times.” The Court found that the Defendants had a duty to: (1) evaluate the mother’s medical background and relay the information to the appropriate parties; (2) consider the appropriate approach to her fourth pregnancy in light of her two prior instances of shoulder dystocia; and (3) use appropriate maneuvers when made aware of the shoulder dystocia. The Court determined that they breached their duty by not reviewing the mother’s relevant medical history when it was clearly available and would have allowed them to make a timely, thoughtful, and effective professional decision of how to handle the pregnancy and labor. The doctor and nurse also breached the duty of care by “pull[ing] on [the child’s] head three times during…labor.” According to the Court, their failure to review the mother’s prior medical history caused the child’s injuries because they otherwise would have identified a C-section as the safest manner to deliver the child, per the Defendant-Doctor’s own admission. Additionally, the Defendants offered no evidence to refute that they “pulled on [the child’s] head three times during…labor,” causing the child’s injuries. In all, the judge awarded the child nearly $6,000,000 in damages and another $400,000 to the parents. OB GYNs, nurse midwives, and other medical professionals in the field of obstetrics and gynecology take note of the message this Federal judge has made loud and clear. Please click here for more information on our Health Law and Regulation Blog.
Final Rule Implementing Section 1557 of the Affordable Care Act: What All Health Care And Coverage Providers Need To Know – Recent blog posting by Michael Manfredi
August 2, 2016
Recent blog posting by Michael Manfredi. All health care providers, programs, and insurers that receive funding from the Department of Health and Human Services need to immediately comply with the requirements imposed by Section 1557 of the ACA. (Covered insurance companies and group health plan providers have until January 1, 2017 to come into compliance). Section 1557 was implemented on July 18, 2016, and it prohibits discrimination based on race, color, national origin, sex, age, or disability in federally-funded health programs. It is the first federal civil rights law to prohibit discrimination based on sex in such programs. This article will focus on what is needed to comply with the gender and language-related aspects of Section 1557.
What Is RequiredUnder Section 1557, affected providers and insurers may not deny care or coverage based on gender, gender identification, or pregnancy. In addition, covered programs and activities must treat individuals consistent with their gender identification. While the rule does not include a religious exemption, it does not displace existing protections for religious freedom and conscience. Covered entities are also required to take reasonable steps to provide meaningful access to non-English speakers likely to be encountered in their territory. This may require looking into local demographics and program statistics. Covered entities are encouraged to develop and implement a comprehensive language access plan consistent with the rest of the Act.
Procedural RequirementsGrievance Procedure: All covered entities with 15+ employees must have a grievance procedure and compliance coordinator. For some, this may prove to be an expensive addition to operating costs. Grievance procedures typically impose timing requirements not only for the complainant, but for the group’s response as well. Compliance coordinators need to know the company’s policies, standards, and rules inside and out. They must also receive training in the new grievance procedure and know the requirements for the coordinator and for the complainant. Language Notices: In addition to implementing a grievance procedure, covered entities are also required to provide notices and taglines advising patients and consumers of the availability of free language assistance services. The taglines must be provided in the top 15 non-English languages spoken in the State. Health care and coverage providers need to immediately move into compliance with the requirements of Section 1557. The rule allows violations to be directly challenged in federal court. To avoid unnecessary litigation fees and costs, become familiar with the new requirements and avoid any delay in making the necessary additions. Please click here for more information on the Health Law and Regulation Update Blog.
Federal Preemption: Determining Whether Federal Law Prevents Pharmaceutical Companies From Being Sued – Recent Blog Posting by Michael Manfredi
July 26, 2016
Recent blog posting by Michael Manfredi. Determining whether your company is subject to liability for a defect in the chemical composition of a drug, or for a failure to adequately warn of dangers associated with the drug, can be a frustrating task. Earlier this month, a federal judge in Georgia gave clarity to pharmaceutical companies facing this issue. The following provides an overview of the federal court guidance taken from the opinion in Brazil v. Janssen Research & Dev. LLC, 2016 U.S. Dist. LEXIS 93528 (N.D. Ga. 2016). With regards to design defects (a problem with the chemical composition of a drug), drug manufacturers cannot be sued for failing to change the formulation of a prescription drug because that type of claim is preempted by federal law. Specifically, FDA regulation 506A requires FDA approval prior to redesigning a drug. Therefore, the remedial action required to avoid liability is prohibited by federal law. The analysis for determining whether your company is protected by federal law for alleged inadequate warnings turns on who holds the approved Application for the New Drug (NDA). The District Court made clear that only the company that filed the NDA can be subject to suit for a failure to warn. “When a company does not have the NDA, it has ‘no more power to change the label’ of a drug than a generic manufacturer.” Brazil, 2016 U.S. Dist. LEXIS 93528, citing In re Darvocet, Darvon, & Propoxyphene Products Liab. Litig., 756 F.3d 917, 940 (6th Cir. 2014). Thus, if your company was involved in the development, design, marketing, or distribution of a drug, then you may have a federal preemption defense to claims for inadequate warnings. Generic manufacturers, likewise, are protected by federal preemption from a failure to warn lawsuit. There are a number of procedural defenses that can serve to minimize or extinguish your company’s exposure to liability. Be sure to consult with counsel as soon as a complaint is made about a drug that your company developed, designed, manufactured, marketed, or distributed. It could save your company tremendous time, money, and stress. Please click here for more information on our Life Sciences Blog.